RXC007 for Idiopathic Pulmonary Fibrosis

Phase 2

Waitlist Available

Led By Philip Molyneaux, MD

Research Sponsored by Redx Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of IPF within 5 years of Screening based on the modified ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management of IPF (Raghu et al, 2018) and confirmed on independent central imaging review

Aged ≥40 to 80 years at the time of signing the informed consent

Must not have

Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication

Lower respiratory tract infection requiring antibiotics within 4 weeks of Screening or during Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21

Summary

This trial tests RXC007, a new drug, for safety and side effects in patients with Idiopathic Pulmonary Fibrosis (IPF). Researchers will measure the drug levels in the blood and its impact on disease markers.

Who is the study for?

This trial is for adults aged 40-80 with Idiopathic Pulmonary Fibrosis (IPF) diagnosed within the last 5 years, having stable lung function and not on certain IPF treatments. Participants can be on nintedanib or pirfenidone if doses have been stable for at least a month. Exclusions include severe other diseases, recent infections, continuous oxygen need over 15 hours/day, and specific contra-indications to bronchoscopy.

What is being tested?

The study tests RXC007's safety and effects over 12 weeks in people with IPF, alone or alongside existing treatments like nintedanib or pirfenidone. It aims to understand how the body processes RXC007 and its impact on IPF symptoms compared to a placebo.

What are the potential side effects?

While specific side effects of RXC007 are not listed here, common risks may include reactions at the injection site, gastrointestinal issues, potential liver enzyme changes, fatigue or respiratory symptoms which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with IPF less than 5 years ago.

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am being treated for IPF with medications not specifically approved for it.

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I have not had a lung infection needing antibiotics in the last 4 weeks.

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I do not have conditions like severe lung or heart issues that make bronchoscopy unsafe for me.

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I need oxygen for more than 15 hours a day.

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My condition is expected to limit my life to less than 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening (day28 to day-1), cycle1 day1 pre-dose and post-dose, cycle1 day8, cycle1 day15, cycle1 day22, cycle2 day1(the day after cycle1 day28), cycle2 day15, cycle3 day1, cycle3 day28, end of treatment: last day of the dosing day 21 for reporting.